Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea
2019; 39(3): 252-262
Ann Lab Med 2013; 33(6): 420-425
Published online November 1, 2013 https://doi.org/10.3343/alm.2013.33.6.420
Copyright © Korean Journal of Laboratory Medicine.
Kyunghoon Lee, M.D., Hyung-Doo Park, M.D., and Eun-Suk Kang, M.D.
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence to: Eun-Suk Kang
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: Early diagnosis of HIV infection reduces morbidity and mortality. Fourth-generation HIV detection assays are more sensitive because they can detect p24 antigen as well as anti-HIV antibodies. In this study, we evaluated the performance of a new fourth-generation ADVIA Centaur HIV antigen/antibody combo (CHIV) assay (Siemens Healthcare Diagnostics Inc., USA) for early detection of HIV infection and reduction of false positive rate. Methods: Four seroconversion panels were included. The third-generation ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay (Siemens Healthcare Diagnostics Inc., USA) and fourth-generation CHIV assay were used to test each panel for HIV infection. The presence of antigen was confirmed using HIV p24 antigen assay. To evaluate false-positivity and specificity, 54 HIV false-positive and HIV-negative serum samples from 100 hospitalized patients and 600 healthy subjects were included. Results: Compared to the EHIV assay, the CHIV assay had a shorter window for three of the seroconversion panels: a difference of 10 days and two bleeds in one panel, and 4 days and one bleed in the other two panels. Only 34 of the 54 (63%) samples known to yield false-positive results by EHIV assay had repeatedly yielded reactive results in the CHIV assay. One of the 600 healthy subjects had a false-positive result with the CHIV assay; thus, the specificity was 99.85% (699/700). CHIV accurately determined the reactive results for the HIV-confirmed serum samples from known HIV patients and Korea Food & Drug Administration (KFDA) panels. Conclusions: The new fourth-generation ADVIA Centaur HIV assay is a sensitive and specific assay that shortens the serological window period and allows early diagnosis of HIV infection.
Keywords: HIV, HIV Combo assay, Seroconversion, Window period, Specificity